FDA 510(k) Cardiovascular Devices
About Cardiovascular Devices
FDA 510(k) cardiovascular devices represent one of the largest device categories, with 17,947 submissions since 1976. The FDA review panel code is CV.
This category covers a wide risk spectrum:
- Class I / II - blood pressure monitors, stethoscopes, ECG systems, holter monitors
- Class II Special Controls - catheters, guidewires, cardiac ablation systems
- Class II / III - pacemakers, implantable defibrillators, stents
Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.
18004
Total
17953
Cleared
125d
Avg days
1976
Since
1063 Cardiovascular devices
Cleared
May 28, 2021
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
DQK
Computer, Diagnostic, Programmable
162d
Cleared
May 27, 2021
BIB Stent Placement Catheter
NVM
Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon
41d
Cleared
May 26, 2021
ViperCath XC Peripheral Exchange Catheter
DQY
Catheter, Percutaneous
30d
Cleared
May 25, 2021
LUX-Dx Insertable Cardiac Monitor
MXD
Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
85d
Cleared
May 25, 2021
HeRO Graft, HeRO Adapter
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
155d
Cleared
May 14, 2021
AcQGuide MAX Steerable Sheath
DRA
Catheter, Steerable
31d
Cleared
May 14, 2021
Cardiac Trigger Monitor
DRT
Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
287d
Cleared
May 12, 2021
ClotTriever Thrombectomy System
QEW
Peripheral Mechanical Thrombectomy With Aspiration
65d
Cleared
May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
NLH
Catheter, Recording, Electrode, Reprocessed
140d
Cleared
Apr 30, 2021
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
QEW
Peripheral Mechanical Thrombectomy With Aspiration
25d
Cleared
Apr 30, 2021
MAC 7 - Resting ECG Analysis System
DPS
Electrocardiograph
123d
Cleared
Apr 29, 2021
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
DWJ
System, Thermal Regulating
59d
Cleared
Apr 15, 2021
Verrata PLUS Pressure Guide Wire
DQX
Wire, Guide, Catheter
77d
Cleared
Apr 08, 2021
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
DXN
System, Measurement, Blood-pressure, Non-invasive
202d
Cleared
Apr 06, 2021
Endovascular Dilator and Sets
DRE
Dilator, Vessel, For Percutaneous Catheterization
26d
Cleared
Apr 06, 2021
AcQCross Qx Integrated Transseptal Dilator/Needle
DYB
Introducer, Catheter
29d
Cleared
Apr 06, 2021
Vascutek Gelsoft Plus ERS Vascular Graft
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
202d
Cleared
Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
DXN
System, Measurement, Blood-pressure, Non-invasive
237d
Cleared
Mar 30, 2021
3M Bair Hugger Temperature Management System (Model 675)
DWJ
System, Thermal Regulating
29d
Cleared
Mar 26, 2021
TandemHeart Pump and Escort Controller
QNR
Blood Pump For Ecmo, Long-term (> 6 Hours) Use
186d
Cleared
Mar 09, 2021
ZOLL Propaq M
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
201d
Cleared
Mar 05, 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
120d
Cleared
Mar 03, 2021
AtriClip LAA Exclusion System
PZX
Left Atrial Appendage Clip, Implantable
29d
Cleared
Mar 03, 2021
WIRION Embolic Protection System
NTE
Temporary Carotid Catheter For Embolic Capture
30d
Cleared
Mar 01, 2021
Recon Support Catheter
DQY
Catheter, Percutaneous
115d
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